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FDA 510(k)

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

K-Number: K251839 · 2025-07-17

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2025-07-17
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-07-17 under approval number K251839. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)?

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) is a medical device that received FDA 510(k) clearance on 2025-07-17. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K251839.

When was uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) approved by the FDA?

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) received FDA 510(k) clearance on 2025-07-17, under approval number K251839.

What company makes uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)?

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) is manufactured by Shanghai United Imaging Healthcare Co., Ltd..

What is the FDA product code for uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)?

The FDA product code for uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) is KPS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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